A case-based evaluation of personalized nutraceutical therapy in PCOD management

*Corresponding author: Ashwathy S Das I Copyright © 2025 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0. A case-based evaluation of personalized nutraceutical therapy in PCOD management A V Srinivasan 1, Ashwathy S Das I 1, *, Srinivas B V 2, Mousumi Mondal 3, Ayan Khanra 4, Manochaya S 4 and Ravindra Kumar Agarwal 5 ¹ Sri Paripoorna Sanathana Ayurveda Medical College, Hospital and Research Centre, No. 91, Kaivalya Sannidhanam, Arjunabettahalli, Kasaba Hobli, Railway Gollahalli Post, Nelamangala Taluk, Bengaluru Rural India 562123. 2 Aspartika Biotech Pvt. Ltd., #7, DITPL, SW-51, Doddaballapura Industrial Area, Doddaballapura, Karnataka, India 561203. 3 Mallipathra Nutraceutical Pvt. Ltd., #25, 7th Cross, Nanjappa Layout, Vidyaranyapura, Bengaluru, Karnataka, India 560097 4 Someys Kitchen Pvt. Ltd., Marsandra, Doddaballapura Main Road, Doddaballapura, Karnataka, India 561203. 5 Sparsh the Wellness Clinique, 2110, 19th B Cross Rd, opp. Rangalakshmi Netralaya, next to Frank Ross Medical, MIG Sector B, Udaya Layout, Yelahanka New Town, Bengaluru, Karnataka, India 560064. World Journal of Biology Pharmacy and Health Sciences, 2025, 22(01), 185-189 Publication history: Received on 26 February 2025; revised on 05 April 2025; accepted on 08 April 2025 Article DOI: https://doi.org/10.30574/wjbphs.2025.22.1.0386 Abstract Polycystic Ovary Disease (PCOD) is a complex endocrine disorder that significantly affects the reproductive and metabolic health of women. Conventional pharmacologic treatments often provide limited success in addressing underlying metabolic dysfunctions. This 12-week observational case study evaluated the effects of a personalized nutraceutical smoothie premix on three women clinically diagnosed with PCOD. The formulation integrated Ayurvedic botanicals, essential micronutrients, and functional food ingredients designed to support hormonal balance and enhance insulin sensitivity. Participants were monitored for clinical parameters, biochemical markers, and patientreported outcomes at baseline and study completion. Notable improvements were observed in total testosterone levels (p<0.05), fasting insulin, and the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR). Additionally, participants reported enhanced overall well-being, improved energy levels, and better menstrual regularity. These preliminary findings suggest that personalized, integrative nutraceutical interventions may offer a promising adjunctive approach to managing PCOD by targeting its metabolic and hormonal dimensions. Keywords: PCOD; Nutraceuticals; Personalized Nutrition; Functional Foods; Women's Health 1. Introduction Polycystic Ovary Disease (PCOD), also referred to as Polycystic Ovary Syndrome (PCOS), is one of the most prevalent endocrine and metabolic disorders affecting 5–10% of women of reproductive age (Goodarzi et al., 2011). Characterized by ovulatory dysfunction, hyperandrogenism, and polycystic ovarian morphology, PCOD often presents with irregular menstruation, infertility, insulin resistance, obesity, acne, and hirsutism (Azziz et al., 2016). The pathogenesis of PCOD is complex, involving genetic, hormonal, and environmental factors. While conventional therapies including oral contraceptives, anti-androgens, and insulin sensitizers such as metformin offer symptomatic control, they are associated with limitations like side effects, poor compliance, and failure to address underlying causes (Legro et al., 2013; Lord et al., 2003). This has led to interest in complementary and integrative treatment modalities including lifestyle changes, dietary interventions, and nutraceuticals. World Journal of Biology Pharmacy and Health Sciences, 2025, 22(01), 185-189 186 Nutraceuticals, defined as food-derived bioactive compounds with health benefits, are increasingly being recognized for their role in metabolic regulation. Inositols, Omega-3 fatty acids, spearmint, cinnamon, and adaptogenic herbs such as Ashwagandha and Shatavari extract have shown promise in improving insulin sensitivity and reducing androgen levels (Unfer et al., 2017; Akilen et al., 2010; Tripathy et al., 2020). This study evaluates the impact of a tailored nutraceutical formulation on clinical and biochemical parameters in three women with PCOD over a 12-week intervention period. 2. Materials and Methods This was a single-arm, non-randomized, observational case series conducted over a 12-week period. The primary objective was to assess the effects of a personalized nutraceutical smoothie premix on clinical symptoms, biochemical markers, and quality of life in women diagnosed with PCOD. 2.1. Smoothie Premix Formulated for trial The intervention involved a standardized smoothie premix formulated based on Ayurvedic principles and recent nutraceutical evidence. Each daily serving (30g) of the premix was reconstituted in 250 ml of A2 Cow milk. It contained: • Ayurvedic herbal extracts of Shatavari (Asparagus racemosus), Ashwagandha (Withania somnifera), Cinnamon (Cinnamomum verum), Spearmint (Mentha spicata) & Fenugreek (Trigonella foenum-graecum) • Vitamins and Minerals: Vitamin B12 (1 mcg), Magnesium (200 mg), Zinc (15 mg), Omega-3 fatty acids (1.2 g from flaxseed and chia seed blend) • Functional Foods: Organic flaxseeds, chia seeds, plant-based protein blend (pea protein & brown rice protein), Soya Protein Hydrolysate, Fructose Oligo Saccharides, Mannan Oligo Saccharides, Inulin, Lactic acid bacillus, Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Bifidobacterium bifidum, Streptococcus thermophilus, Alpha amylase, Protease, Lipase, Cellulase, Bromelain & Alpha galactosidase and Psyllium Husk. The women in the case study also adhered to a gluten-free, lactose-free, and completely satvik diet throughout the intervention period. 2.2. Study Plan Three female participants aged between 24 and 30 years, previously diagnosed with PCOD per Rotterdam Criteria (2003), were included. Inclusion: oligomenorrhea/amenorrhea, hyperandrogenism (clinical/biochemical), insulin resistance, and no recent hormonal or fertility treatments. • Exclusion: pregnancy, lactation, other endocrine disorders, or known allergies to formulation components. Assessments were done at baseline and week 12 including: • Clinical: menstrual cycle, acne, hirsutism (Ferriman-Gallwey scale) • Biochemical: serum testosterone, fasting insulin, LDL, HDL, HOMA-IR • Patient-reported: energy, mood, quality of life Data were analyzed using paired t-tests. Significance was set at p<0.05. 3. Results All three participants exhibited marked improvements in both biochemical and clinical outcomes over the 12-week intervention period. Notably, there was a consistent reduction in serum total testosterone levels, fasting insulin concentrations, and HOMAIR scores, indicating a positive effect on hyperandrogenism and insulin resistance. Additionally, a decline in LDL cholesterol were observed, reflecting improved lipid metabolism (Table 1). Clinically, all participants reported improved menstrual regularity, with two achieving ovulatory cycles by week 12. Acne severity reduced significantly, and hirsutism scores, assessed via the Ferriman-Gallwey scale, showed a downward trend (Figure 1). These outcomes suggest modulation of androgenic activity and improved hormonal balance. World Journal of Biology Pharmacy and Health Sciences, 2025, 22(01), 185-189 187 Subjective evaluations also supported these findings. Participants reported enhanced mood, sustained energy levels, and improved quality of life based on self-assessment questionnaires administered at each interval (Table 2). The integration of functional foods, adaptogenic herbs, and micronutrients appears to have played a synergistic role in addressing the underlying metabolic and hormonal dysregulation associated with PCOD. These results align with existing literature on the therapeutic potential of inositols, adaptogens such as Ashwagandha, and dietary Omega-3s in managing PCOD symptoms through improvement in insulin sensitivity and reduction in androgen levels. This study supports the feasibility of personalized nutraceutical interventions as a complementary therapy in PCOD management. Table 1 Changes in Biochemical Parameters at Baseline and Week 12 Parameter Particip ant 1 (Baselin e) Particip ant 1 (Week 12) Particip ant 2 (Baselin e) Particip ant 2 (Week 12) Particip ant 3 (Baselin e) Particip ant 3 (Week 12) Mean Change ± SD pval ue Serum Testosterone (ng/dL) 78 48 72 50 80 54 ↓ 25.3 ± 2.5 ng/dL <0.0 5 Fasting Insulin (µIU/mL) 22 14 19 12 24 15 ↓ 7.3 ± 0.9 µIU/mL <0.0 5 HOMA-IR 5.1 2.9 4.6 2.6 5.4 3 ↓ 2.2 ± 0.2 <0.0 5 LDL Cholesterol (mg/dL) 142 118 136 110 148 120 ↓ 24.6 ± 2.0 mg/dL <0.0 5 HDL Cholesterol (mg/dL) 38 42 40 44 35 40 ↑ 4.6 ± 0.9 mg/dL >0.0 5 Bar Chart Description: X-axis: Participant Number (1, 2, 3); Y-axis: Ferriman-Gallwey Score; Bars: Two per participant – Baseline and Week 12 Figure 1 Improvement in Ferriman-Gallwey Scores for Hirsutism Across 12 Weeks World Journal of Biology Pharmacy and Health Sciences, 2025, 22(01), 185-189 188 Table 2 Patient-Reported Outcomes at Baseline and Week 12 Outcome Participant 1 (Baseline) Participant 1 (Week 12) Participant 2 (Baseline) Participant 2 (Week 12) Participant 3 (Baseline) Participant 3 (Week 12) Trend Energy Levels (0– 10) 4 8 5 9 3 7 ↑ Improved Mood Stability (0–10) 5 8 6 9 4 8 ↑ Improved Quality of Life (0–10) 4 8 5 9 3 8 ↑ Improved Menstrual Regularity Irregular Regular Irregular Regular Irregular Partial Regularity ↑ Improved Acne Severity (0–5 scale) 4 1 5 2 4 2 ↓ Reduced 4. Discussions The findings of this observational study support the therapeutic potential of a personalized nutraceutical intervention in managing the complex hormonal and metabolic dysregulation associated with PCOD. The observed improvements in serum testosterone levels, insulin resistance (HOMA-IR), and lipid profile (notably LDL cholesterol) are indicative of the formulation’s role in modulating endocrine and metabolic pathways. Clinically, enhanced menstrual regularity, reduced acne severity, and lowered hirsutism scores suggest a positive influence on androgen excess, one of the key pathophysiological features of PCOD. Subjective reports of improved mood and energy further highlight the formulation’s potential in addressing quality-of-life aspects often overlooked in conventional management. These results are consistent with existing literature on the role of inositols, cinnamon, Omega-3 fatty acids, and adaptogenic botanicals in improving insulin sensitivity and androgen balance. 5. Conclusion The 12-week intervention with a personalized nutraceutical smoothie premix showed encouraging improvements in clinical, hormonal, and metabolic parameters among women with PCOD. These preliminary findings underscore the potential of integrative nutraceutical strategies in managing complex endocrine disorders. Further large-scale studies are warranted to validate these outcomes and establish broader clinical applicability. Compliance with ethical standards Acknowledgments The authors thank Sri Paripoorna Sanathana Charitable Trust, Someys Kitchen Pvt. Ltd., Aspartika Biotech Pvt. Ltd., and Mallipathra Nutraceutical for their support. Disclosure of conflict of interest The authors declare no conflict of interest. References [1] Goodarzi MO, Dumesic DA, Chazenbalk G, Azziz R. 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